(168 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
A MEDICAL GLOVE IS WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
Latex Patient Examination glove Powderfree (blue color) Polymer coated
Based on the provided text, the acceptance criteria and device performance for the Siam Sempermed D Corporation's Latex Patient Examination Glove Powderfree are as follows:
1. Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (ASTM Standard / Specification) | Reported Device Performance |
|---|---|---|
| DIMENSION | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Overall length | 230 mm MIN. | 240 +/- 10 mm |
| Width (double wall) | S 80 +/- 10 mm; M 95 +/- 10 mm; L 111 +/- 10 mm | SS ≤ 80 mm; S 83 +/- 5 mm; M 94 +/- 5 mm; L 105 +/- 4 mm; XL 110 +/- 5 mm |
| Thickness, mm | ||
| Finger | 0.08 mm MIN. | 0.08 mm MIN. |
| Palm | 0.08 mm MIN. | 0.08 mm MIN. |
| PHYSICAL PROPERTIES | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Before Aging Tensile strength | According to ASTM D3578-95 | 14 Mpa MIN. |
| Before Aging Elongation at break | According to ASTM D3578-95 | 700% MIN. |
| After Aging Tensile strength | 14 Mpa MIN. | |
| After Aging Elongation at break | 500% MIN. | |
| WATER EXTRACTABLE PROTEIN | N/A | S-2 AQL 4.0 |
| POWDER LEVEL | N/A | 2 mg MAX. |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |
The document states: "Siam Sempermed Latex Patient Examination Glove Powderfree (blue color) polymer coated meet the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims". This indicates that the reported device performance meets or exceeds all the specified acceptance criteria.
2. Sample size used for the test set and the data provenance
The document specifies "S-2 AQL 4.0" for dimensions and physical properties, "S-4 AQL 4.0" for freedom from hole, and "II AQL 1.5" for freedom from hole. AQL (Acceptable Quality Limit) refers to an inspection level and a sampling plan, but the exact sample size (n) for the test set is not explicitly stated in the provided text. The data provenance is from Siam Sempermed D Corporation, Ltd in Thailand, and the study appears to be prospective manufacturing quality testing to ensure the product meets specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The evaluation criteria are based on objective physical and chemical properties and ASTM standards, which typically do not involve expert consensus in the same way medical imaging or diagnostic devices might.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the context of this device. The assessment is based on measured physical and chemical properties against established standards, not on subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or is relevant for this device. This is a medical glove, a Class I device, and its performance is evaluated based on physical characteristics and material properties, not on diagnostic performance aided by AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm-only performance testing was done or is relevant for this device. This device is a physical product (a glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is based on objective measurements against established engineering and material standards, specifically ASTM D3578-95 and internal specifications for dimensions, physical properties, water extractable protein, powder level, and freedom from holes. For "Freedom from Hole," it also refers to "pinhole FDA requirements."
8. The sample size for the training set
There is no "training set" in the context of this device. It is not an AI/ML or diagnostic device that requires training. The described process is a quality control and conformity assessment against manufacturing standards.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.